BEUDAMED
    FDA Enforcement Class II Terminated

    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).

    Recall: Z-2677-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2677-2014
    Event ID
    67900
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genesys Orthopedics Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    April 2, 2014
    Classification Date
    September 22, 2014
    Termination Date
    May 15, 2015
    Address
    1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin, TX, 78746-6446, United States

    Description

    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).

    Reason

    The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.

    Code Info

    The devices being recalled have a catalog number of G826 and a lot number of 11406.

    Distribution

    Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.

    Quantity

    642